Adamis Pharmaceuticals files sNDA for Symjepi for the emergency treatment of anaphylaxis.
Adamis Pharmaceuticals Corporation announced that the FDA has accepted for review the Company�s supplemental New Drug Application (�sNDA�) for its low dose Symjepi product candidate for the emergency treatment of anaphylaxis. On February 9, 2018, Adamis received FDA correspondence relating to the company�s sNDA stating that the Agency had completed their filing review and had determined that the sNDA was sufficiently complete to permit a substantive review.
The FDA further indicated that no potential review issues were identified and if no major deficiencies were identified in their continued review, they are targeting 3 September 2018 to communicate proposed labeling and, if necessary, any postmarketing requirement/commitment requests.
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